“This quarter, we made important progress on our development plans across our clinical pipeline,” stated
“More recently, we also received health authority approval in
Key Highlights in the Second Quarter and Subsequent Weeks, Included:
- Enrolled the first patient in Bellerophon’s Phase 3 INOvation-1 clinical trial to treat PAH. The first patient was enrolled in June by Jeremy Feldman, MD, Principal Investigator at Arizona Pulmonary Associates, Ltd.
- Enrolled the first patient in the Company’s Phase 2 trial to evaluate the safety and efficacy of the INOpulse® delivery system in patients with PH-IPF in collaboration with Professor W. De Backer, MD,
Director Department of Pulmonary Medicine , University Hospital and University of Antwerp. - Received Belgian health authority approval in July to commence the planned Phase 2 trial for INOpulse to treat PH-COPD. This follows results from the Company’s Phase 2a study and proof of mechanism work, which indicated that INOpulse could be both safe and effective in PH-COPD.
- The positive results of a trial conducted in the Department of Respiratory Medicine at the University Hospital Antwerp, by Professor
W. De Backer , MD and Bellerophon, were published in July in the peer-reviewedInternational Journal of COPD (Hajian et al., Pulmonary vascular effects of pulsed inhaled nitric oxide in COPD patients with pulmonary hypertension,International Journal of COPD , 2016, 11:1533-1541). - Entered into an At Market Issuance Sales Agreement, or ATM Offering, with
FBR Capital Markets & Co. , which allows Bellerophon to issue and sell common stock having an aggregate offering price of up to$5.7 million . During the second quarter endedJune 30, 2016 , Bellerophon received$0.7 million in gross proceeds from such sales and duringJuly 2016 , received another$1.5 million .
Second Quarter 2016 Financial Results
For the second quarter ended
Research and development expenses for the second quarter declined 53 percent to
General and administrative expenses (G&A) for the second quarter of 2016 declined 65 percent to $1.2 million, from $3.4 million a year ago. G&A expenses were lower primarily as a result of lower expenses payable to Ikaria, Inc. as a result of the termination in
At
About Bellerophon
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing three product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery device. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company has commenced Phase 3 clinical trials in 2016. The second is for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) and the third candidate is for the treatment of pulmonary hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF) both of which are in Phase 2 development. The Company’s plans call for the completion of further work on the use of INOpulse to treat PH-COPD and PH-IPF during 2016. For more information, please visit www.bellerophon.com.
Forward-looking Statements
Any statements in this press release about Bellerophon’s future expectations, plans and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Company’s clinical trials and expectations regarding the sufficiency of the Company’s cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, the FDA’s substantial discretion in the approval process, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of the Company’s most recent filings with the
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | ||||||||||||||||
| (in thousands except share and per share data) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 3,954 | $ | 8,426 | $ | 9,067 | $ | 17,946 | ||||||||
| General and administrative | 1,205 | 3,435 | 3,181 | 8,008 | ||||||||||||
| Total operating expenses | 5,159 | 11,861 | 12,248 | 25,954 | ||||||||||||
| Other operating income | — | 251 | — | 1,417 | ||||||||||||
| Loss from operations | (5,159 | ) | (11,610 | ) | (12,248 | ) | (24,537 | ) | ||||||||
| Interest income | 22 | 27 | 52 | 46 | ||||||||||||
| Pre-tax loss | (5,137 | ) | (11,583 | ) | (12,196 | ) | (24,491 | ) | ||||||||
| Income tax benefit (expense) | — | — | — | — | ||||||||||||
| Net loss | $ | (5,137 | ) | $ | (11,583 | ) | $ | (12,196 | ) | $ | (24,491 | ) | ||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic and diluted | 13,093,176 | 12,910,975 | 13,073,202 | 11,554,593 | ||||||||||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.39 | ) | $ | (0.90 | ) | $ | (0.93 | ) | $ | (2.12 | ) | ||||
| BELLEROPHON THERAPEUTICS, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) | ||||||||
| (in thousands except share and per share data) | ||||||||
| As of | As of | |||||||
| June 30, 2016 | December 31, 2015 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,304 | $ | 6,260 | ||||
| Marketable securities | 11,920 | 17,807 | ||||||
| Prepaid expenses and other current assets | 5,405 | 5,385 | ||||||
| Total current assets | 18,629 | 29,452 | ||||||
| Restricted cash, non-current | 457 | 457 | ||||||
| Other non-current assets | 5,595 | 6,701 | ||||||
| Property and equipment, net | 1,597 | 1,799 | ||||||
| Total assets | $ | 26,278 | $ | 38,409 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,020 | $ | 1,613 | ||||
| Accrued research and development | 2,394 | 2,825 | ||||||
| Accrued expenses | 1,673 | 3,487 | ||||||
| Due to Ikaria, Inc. | 126 | 148 | ||||||
| Total current liabilities | 6,213 | 8,073 | ||||||
| Total liabilities | 6,213 | 8,073 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.01 par value per share; 125,000,000 shares authorized, 13,920,597 and 13,130,800 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 139 | 131 | ||||||
| Preferred stock, $0.01 par value per share; 5,000,000 share authorized, zero shares issued and outstanding at June 30, 2016 and December 31, 2015 | — | — | ||||||
| Additional paid-in capital | 132,798 | 130,902 | ||||||
| Accumulated other comprehensive income (loss) | 2 | (19 | ) | |||||
| Accumulated deficit | (112,874 | ) | (100,678 | ) | ||||
| Total stockholders’ equity | 20,065 | 30,336 | ||||||
| Total liabilities and stockholders’ equity | $ | 26,278 | $ | 38,409 | ||||
Contacts At Bellerophon:Fabian Tenenbaum , Chief Financial Officer (908) 574-4767At Rx Communications Group :Melody Carey (917) 322-2571